MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335754

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Injury (2348)

Event Date 04/01/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to stiffening.Cup, poly, stem and head were removed.

Manufacturer Narrative

It was reported that a revision surgery was performed due to stiffening.The associated oxinium femoral head, r3 acetabular liner and anthology porous femoral component standard offset were not returned for evaluation.Thus a product evaluation could not be performed.However, device details were provided.The manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.The clinical evaluation noted the provided x-rays do not indicate a reason for the reported stiffness.Based on the information provided the reported pain and stiffening was due to the stem being loose.It was communicated that the stem had no bony ingrowth, which surgeon thought that polar stem might have been an option due to patients bone quality.The future impact to the patient beyond the revision cannot be determined.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8547329
• MDR Text Key: 143021077
• Report Number: 1020279-2019-01668
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598349
• UDI-Public: 03596010598349
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71335754
• Device Lot Number: 17GM16998
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PART NUMBER 71330001 / LOT NUMBER 17JM10970; PART NUMBER 71332525 / LOT NUMBER 16MB00063
• Patient Outcome(s): Hospitalization; Required Intervention